Nomenclature of medical devices in the “product portfolio” of pharmaceutical companies:
Requirements of the international standard ISO 13485: 2018 Medical devices – Quality management systems – Requirements for regulatory purposes.
Requirements of the national standard DSTU EN ISO 13485: 2018 Medical devices. Quality management system. Regulatory requirements
The procedure for conducting audits of the QMS of companies producing medical devices.
Nikolay Matlaev, Lead Auditor of the Conformity Assessment Department of the Ukrainian Scientific Institute of Certification
After the events of 2014, Ukraine took the path of development, oriented towards the European Union. On September 1st, 2017, the Association Agreement between Ukraine and the EU entered into force. Ukraine assumed the responsibility to follow the path of harmonization with EU legislation and, as a result, some changes took place in the regulatory […]Read more
Journal “Laboratory” No. 07/2020 The text of the article is available only in UkrainianRead more
PROGRAM Temporary changes in the rules of import of medical devices and personal protective equipment needed to prevent the COVID-19 Conformity assessment procedures: self-declaration or assessment with the involvement of a designated body Requirements for accompanying documentation: labeling, instructions for use, declaration of conformity Application of the requirements of the Law of Ukraine “On ensuring […]Read more